FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing
The Food and Drug Administration (FDA) is announcing a 1-day public hearing to obtain input on certain questions related to the implementation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). This public hearing is being held to obtain comments from the public on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and to request input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence.
Date: December 17, 2012
Time: 8:00 a.m. to 5:00 p.m.
Location: FDA White Oak Campus
Building 31, Room 1503
10903 New Hampshire Avenue
Silver Spring, MD 20993
- Federal Register Notice (PDF - 236KB)
- Agenda (PDF - 48KB)
- Transcript, Monday, December 17, 2012 (PDF - 656KB)
All meeting attendees must enter through Building 1 on the FDA White Oak Campus. Parking is available in the Southeast surface lot and a shuttle bus will be available to bring attendees from the lot to Building 1. Please see Directions/Transportation/Parking/Hotels for the FDA White Oak Campus (PDF - 115KB) for directions and further details about transportation and lodging. Map of White Oak Visitor Parking (PDF - 105KB)
Webcast of Meeting
For those unable to attend in person the meeting will also be webcast. You may access the webcast via this link: https://collaboration.fda.gov/Section918
Requirements and instructions for accessing the webcast are below.
Adobe Connect Minimum Requirements
- View meetings on Windows, Macs, Unix, and Linux platforms
- Lan or Broadband internet connection
- Supports Internet Explorer, Firefox, Safari, Netscape Navigator, AOL
- Adobe Flash Player (no other downloads needed)
- VPN and Parachute compatible but not required
- Test my computer for Adobe Connect-Readiness
Attendance and Registration to Speak
The FDA Conference Center at the White Oak location is a federal facility with limited seating so attendance will be on a first come-first served basis.
Individuals who wish to speak must register by sending an e-mail to Section918PublicMeeting@fda.hhs.gov and provide complete contact information for each speaker, including name, title, affiliation, address, e-mail, and phone number. FDA will do its best to accommodate requests to speak and will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin.
If you need special accommodations because of disability, please contact Ayanna Augustus, phone (301)796-3980, e-mail Section918PublicMeeting@fda.hhs.gov at least 7 days before the meeting.